Salmosan target animal safety testing
1 Purpose
This project is to support a label claim expansion to the existing Sallmosan Vet label, by documenting margin of safety and human food safety when treating seawater phase Atlantic salmon in extended exposure conditions.
2 Distress
The project is not expected to cause significant additional stress beyond that already documented with the licencing of Salmosan Vet in Norway. Moreover, the application and efficacy will be also be confirmed on fish with sealice infestations (positive control).
3 Expected benefit
The extended exposure potential will allow for the generation of data to support a product label change application in Norway/NoMA and UK/VMD. Thus ensuring greater efficacy during treatments and potentially fewer subsequent treatments being required for treating againast sea lice in Atlantic salmon..
4 Number of animals, and what kind
360 Atlantic salmon post-smolts will be used in this study, housed and exposed in RAS systems.
5 How to adhere to 3Rs
The Use of RAS in this exposure testing ensures minimal handling and disturbance/stress to the fish during the treatment exposure. This minimises the number of fish required to testing as well as ensuring the best fish welfare and monitoring possible during the validation process required by the Norwegian Medicines Authority. Key to teh number of animals used in this study is based on teh minimum amount of fish needed for testing per GLP and/or GCP guidance on target animal safety testing, and residues studies. While the live phase of the project does not claim GLP compliance (RASLab is not GLP accredited), the study will be run in the spirit of GLP and supported by Benchmark Animal Health development and quality managers.
This project is to support a label claim expansion to the existing Sallmosan Vet label, by documenting margin of safety and human food safety when treating seawater phase Atlantic salmon in extended exposure conditions.
2 Distress
The project is not expected to cause significant additional stress beyond that already documented with the licencing of Salmosan Vet in Norway. Moreover, the application and efficacy will be also be confirmed on fish with sealice infestations (positive control).
3 Expected benefit
The extended exposure potential will allow for the generation of data to support a product label change application in Norway/NoMA and UK/VMD. Thus ensuring greater efficacy during treatments and potentially fewer subsequent treatments being required for treating againast sea lice in Atlantic salmon..
4 Number of animals, and what kind
360 Atlantic salmon post-smolts will be used in this study, housed and exposed in RAS systems.
5 How to adhere to 3Rs
The Use of RAS in this exposure testing ensures minimal handling and disturbance/stress to the fish during the treatment exposure. This minimises the number of fish required to testing as well as ensuring the best fish welfare and monitoring possible during the validation process required by the Norwegian Medicines Authority. Key to teh number of animals used in this study is based on teh minimum amount of fish needed for testing per GLP and/or GCP guidance on target animal safety testing, and residues studies. While the live phase of the project does not claim GLP compliance (RASLab is not GLP accredited), the study will be run in the spirit of GLP and supported by Benchmark Animal Health development and quality managers.